欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
AT/H/0672/001
药品名称
Xorox 30 mg/g Augensalbe
活性成分
aciclovir 30.0 mg/g
剂型
Eye ointment
上市许可持有人
AGEPHA Pharma s.r.o Diaľničná cesta 5 90301 Senec, Slovakia
参考成员国 - 产品名称
Austria (AT)
互认成员国 - 产品名称
Germany (DE)
Xorox 30 mg/g Augensalbe
Denmark (DK)
Xorox
Belgium (BE)
Aciclovir Agepha 30 mg/g oogzalf
Netherlands (NL)
Luxembourg (LU)
Iceland (IS)
Xorox 30 mg/g Augnsmyrsli
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Sweden (SE)
Norway (NO)
Finland (FI)
Poland (PL)
Xorox
Latvia (LV)
Xorox 30 mg/g acu ziede
Estonia (EE)
ACICLOVIR AGEPHA
Hungary (HU)
Xorox 3% szemkenőcs
Cyprus (CY)
Xorox 3% eye oitment
Czechia (CZ)
Xorox 3% oční mast
Romania (RO)
Malta (MT)
Croatia (HR)
Xorox 30 mg/g mast za oko
Slovenia (SI)
许可日期
2019/03/05
最近更新日期
2022/06/07
药物ATC编码
S01AD03 aciclovir
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Initial Application
TypeLevel3：
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
PAR
|
PAR_AT_H_0672_001_1
Date of last change:2022/07/29
Final SPC
|
final SmPC AT_H_0672_001_IB_002 clean
Date of last change:2021/04/26
Final Product Information
|
AT_H_0672_001_IA_001_APPROVAL LETTER
Date of last change:2020/07/22
Final PL
|
AT_H_0672_001_MR_final_PL
Date of last change:2019/11/29
Final Labelling
|
AT_H_0672_001_MR_final_PL
Date of last change:2019/11/29
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase